Compliance

Teva Pharmaceuticals USA, Inc. (Teva) and its divisions and affiliated U.S. companies, are committed to conducting business in compliance with all applicable federal and state statutes and regulations.

To help ensure this compliance, Teva has established and will maintain an effective Compliance Program in accordance with the OIG Compliance Program Guidance for Pharmaceutical Manufacturers ("OIG Guidance") issued by the Office of Inspector General, U.S. Department of Health and Human Services. Our Compliance Program is one of the key components of our commitment to fostering a culture of compliance where it is understood that integrity is the bottom line.

The OIG Guidance sets forth the federal government's views on the value and fundamental principles of compliance programs for pharmaceutical manufacturers and the specific elements that manufacturers should consider when developing and implementing an effective compliance program. The OIG Guidance is a major initiative in support of the federal government's efforts in preventing and reducing fraud and abuse in the sales and marketing of pharmaceutical products.

The purpose of Teva's Compliance Program is to prevent and detect violations of law or company policy. As the OIG Guidance recognizes, the implementation of such a program cannot guarantee that improper employee conduct will be entirely eliminated. Nonetheless, it is Teva's expectation that employees will fully comply with the policies and procedures established in support of our Compliance Program. In the event that Teva becomes aware of violations of law or company policies and procedures, we will investigate the matter and, where appropriate, take disciplinary action and implement corrective measures to prevent future violations.

Teva's relationships with healthcare professionals are intended to benefit patients and to enhance the practice of medicine. All of Teva’s interactions with healthcare professionals should be focused on informing the healthcare professionals about products, providing scientific and educational information, and supporting medical research and education.

Teva recognizes the seriousness and critical need to establish and maintain a compliance program consistent with the OIG Guidance. As described below, Teva has established a Compliance Program aligned with the philosophy and specific requirements of the OIG Guidance. Consistent with the OIG Guidance, we have tailored our Compliance Program to fit the unique environment of Teva. We regularly review and enhance our Compliance Program to meet our evolving compliance needs.

1. Written Policies & Procedures

Teva has in place various policies and procedures that are intended to: 

• Help assure compliance with US laws, regulations and industry guidance; and
• Assure consistency in the way that Teva conducts its business.

These policies include but are not limited to Teva’s global Code of Conduct, US Generic Commercial Policy and US Compliance Policy Play Books.. The Code of Conduct sets forth our basic standards — standards which are based on Teva's fundamental values. The Code provides us with a common set of ethical standards and a common language for describing what is, and what is not, within the realm of ethical conduct. The Generic Commercial policy is designed to bring our Core Principles to life and ensure activities always aspire to the highest standards of integrity and professionalism. The US Compliance Policy Playbooks are role-based and provides a foundation to help frame our interactions with US Specialty Medicines Customers to ensure business is conducted in an ethical manner and within the confines of the law.

Company procedures implement the concepts found in these policies to provide employees with more specific instruction with respect to business practices that the OIG Guidance identified as falling within three risk areas, namely (1) data integrity pertaining to government reimbursement practices, (2) kickbacks and other illegal remuneration, and (3) compliance with laws regulating drug samples.

Pursuant to California law, Teva has established an annual spending limit of $3,000 on educational items and meals provided to healthcare professionals licensed in California. These items and activities consist of: 

• Business meals provided in connection with informational presentations and discussions relating to a Teva product, and
• Educational items intended to advance disease or treatment education

The annual limit is an estimate of the maximum amount spent on these promotional items and activities. Few California healthcare professionals will actually reach this limit and the limit is not a spending goal.

This limit does not include the value of written promotional and educational materials, including reprints of peer-reviewed journal articles, provided to healthcare professionals in connection with informational presentations and discussions about Teva products.

This limit is in effect until June 30, 2024. Teva may periodically re-evaluate this limit and, if appropriate, make any necessary adjustments.

2. Compliance Officer & Compliance Committee

Teva's Global Compliance Department is headed by the Global Compliance Officer. Teva’s NA Compliance Department is headed by the NA Compliance Officer. Teva is committed to ensuring that the Compliance Officers have the ability to implement change within the company as necessary and to exercise independent judgment. The Compliance Department is charged with the responsibility for establishing and maintaining the Compliance Program. 

The Compliance Department works closely with and seeks the advice and counsel of the Compliance Committees in the implementation of the Compliance Program. The Compliance Committees are made up of senior-level leaders at Teva.

3. Training & Education

Critical to the success of Teva's Compliance Program is each individual employee's understanding of the Program and the policies and procedures established as part of that Program. Teva is committed to effectively communicating company policies and procedures to its employees and other personnel to ensure that they have an understanding about and appreciation for how to conduct their business practices appropriately. Teva also will regularly review and update its training programs to ensure their effectiveness and will work to identify additional areas of training.

4. Lines of Communication

Teva is committed to fostering dialogue between management and employees about reporting concerns or questions about non-compliance. All Teva employees have a responsibility to report misconduct (either suspected or confirmed) and are encouraged to discuss these questions or concerns with their own manager or other members of the management team. Teva employees may also report non-compliance to the Teva Integrity Hotline, which is available toll-free, 24 hours a day. Information on how to make a report can be found on the Global Compliance page of teva.net. Reports made to the hotline will be investigated by Teva’s Office of Business Integrity (OBI). The company has a firm policy prohibiting retaliation against any individual who reports a concern in good faith. If you have any questions about the Teva Integrity Hotline or the OBI’s investigative process, please contact the OBI at Office.BusinessIntegrity@tevapharm.com.

5. Auditing & Monitoring

Teva utilizes auditing and monitoring to verify that the business practices engaged in by its employees follow the various policies and procedures that are in place to ensure compliance with the laws and regulations applicable to the company. The Compliance Department identifies potential risk areas on which to focus its auditing and monitoring activities. As recognized in the OIG Guidance, the extent and frequency of the company's auditing and monitoring activities varies according to a number of factors, including new regulatory requirements and changes in business practices.

6. Disciplinary Action

Failure to comply with our established policies, procedures, and the overall Teva Compliance Program will be treated as a breach of company policy and will result in appropriate disciplinary action, up to and including termination for Teva employees. Although each situation is considered on a case-by-case basis, we will consistently undertake appropriate disciplinary action to address non-compliance and deter future violations.

7. Investigations

Teva will investigate suspected non-compliance with its policies and procedures as well as all applicable laws and regulations in a manner designed to promptly and accurately ascertain the facts and to determine the underlying cause or causes of any substantiated, non-compliant conduct. The investigation will assess whether the non-compliance is due to gaps in policies or internal controls and take appropriate action to address any gaps so as to prevent future violations. The Compliance Department will direct investigations of suspected non-compliance and document the nature and results of such investigations. As mentioned above, reports of non-compliance made through the Teva Integrity Hotline will be investigated through Teva’s Office of Business Integrity.

8. California Health and Safety Code

July 1, 2023 - Teva USA and its US-based affiliates to which California Health and Safety Code 119400-119402 (the “Act”) applies declare that to the best of its knowledge, information, and belief, it is in material compliance with its Compliance Program and its good faith understanding of the requirements of California Health and Safety Code 119400-119402. Teva has developed a Compliance Program reasonably tailored to the size, organizational structure, and resources of the company and the program is reasonably intended to satisfy the compliance goals set forth by the State of California. Our Compliance Program is reasonably designed to prevent and detect violations but by making this declaration, Teva USA does not assert that it can prevent individual employees from engaging in improper conduct. For a copy of Teva’s Compliance Program or a written declaration of compliance, call 1-888-838-2872.